Composition and method of treating cancer with tannic acid and tannin complexes

ABSTRACT

A pharmaceutical composition including tannic acid and tannin complexes, and a method of treating cancer with tannic acid and tannin complexes.

This application is a division of application Ser. No. 08/398,600 filedMar. 3, 1995.

TECHNICAL FIELD

The present invention relates to a pharmaceutical composition comprisingtannic acid or tannin complexes, and a method of treating cancer withtannic acid or tannin complexes.

BACKGROUND ART

Tannic acid and tannin complexes are found in the trunk of any of theplants of the Musaceas Family, i.e., Musa Paradisiaca, Musa CavendishEnano, and related Linneo Classifications.

Tannic acid is known to be useful in a diagnostic test for the detectionof cancer. For example, Macartney et al. in J Pathol (ENGLAND) September1979, 129 (1) p13-20, “Intracellular filaments in human cancer cells: ahistological study”, discloses that the distribution of intracellularfilamentous systems in human breast and colonic cancers has beendemonstrated by means of the tannic acid-phosphomolybdic acid-millingdye staining technique. Plasma membrane-associated staining is prominentin breast carcinomas and is strongest in anaplastic tumors. Strongstaining is also noted in the cells at the margins of the tumors wherethe malignant cells are invading the surrounding tissues. In coloniccarcinomas, filaments are mainly restricted to the terminal web regionof the cells but dedifferentiation is accompanied by the development ofcircumferential staining of the cell membrane. The results are discussedin relation to immunohistochemical and electron microscopic studies ofcontractile proteins in non-muscle cells.

Harlos et al. in J Cancer (DENMARK) Apr. 15, 1978, 21 (4) p 413-7,discloses a “Comparison between the macrophage electrophoretic mobility(MEM) and the fixed tanned erythrocyte electrophoretic mobility (FTEEM)tests in the detection of cancer.” When peripheral lymphocytes frompatients with a history of cancer are incubated with encephalitogenicfactor (EF), in 90% of cases the resulting products reduce the netsurface negativity of guinea-pig macrophages, used as detector cells, asrevealed in the macrophage electrophoretic mobility (MEM) test. The MEMtest is positive in 36% of people with no history of cancer.Formaldehyde-fixed tanned sheep erythrocytes have been used as detectorcells in place of guinea-pig macrophages, in a fixed tanned erythrocyteelectrophoretic mobility (FTEEM) test, with lymphocyte productsidentical to those used in MEM tests. In patients with a history ofcancer, positive results were obtained in 28/42 cases with the FTEEMtest compared with 32/42 in the MEM test. In people with no history ofcancer, negative results were obtained in 16/18 cases with the FTEEMtest, compared with 12/18 in the MEM test in the present series, and51/69 in a more extensive series. These differences are not significant.Cases in which discrepancies are revealed between the two tests arediscussed in terms of individual case histories.

Tannic acid has been shown to inhibit12-O-tetra-decanoyl-phorbol-13-acetate (TPA). Perchellet et al., BasicLife Sci (UNITED STATES) 1992, 59 p. 783-801, discloses that naturallyoccurring plant phenols with antimutagenic and anticarcinogenicactivities were tested for their abilities to inhibit the biochemicaland biological effects of the potent tumor promoter12-O-tetradecanoyl-phorbol-13-acetate (TPA) in mouse epidermis in vivo.When applied topically to mouse skin, tannic acid (TA), ellagic acid,and several gallic acid derivatives all inhibited TPA-induced ornithinedecarboxylase activity, hydroperoxide production, and DNA synthesis,three biochemical markers of skin tumor promotion. In a two-stepinitiation-promotion protocol, the same phenolic compounds alsoinhibited the incidence and yield of skin tumors promoted by TPA.

Ramanathan et al. in “Cytotoxic effect of plant polyphenols andfat-soluble vitamins on malignant human cultured cells”, Cancer Lett(NETHERLANDS) Mar. 15, 1992, 62 (3) p. 217-24, discloses in vitrostudies which showed that several flavonoids, tannic acid, gallic acidand fat-soluble vitamins inhibited HeLa and Raji lymphoma cell growth.The inhibition trend exhibited by these compounds was similar for bothcell lines, and their growth was inhibited dose dependently. Butein, (10microM), the most potent anti-proliferative agent, exerted 30% growthinhibition and was more effective on HeLa cells. Retinol (100 microM)inhibited cell proliferation completely. Tannic acid was twice as potentas its monomer gallic acid. From structure-activity consideration, the C2,3-double bond of the flavonoid molecule was important for activity.Flavonoid aglycones were more effective than their correspondingglycosides in suppressing cell growth in vitro. No in vivo results werepresented.

Athar et al., “Effect of dietary tannic acid on epidermal, lung, andforestomach polycyclic aromatic hydrocarbon metabolism andtumorigenicity in Sencar mice,” Cancer Res (UNITED STATES) Nov. 1, 1989,49 (21) p. 5784-8, discloses tannic acid inhibits the mutagenicity ofseveral polycyclic aromatic hydrocarbons (PAHs) and their bay-regiondiol-epoxides. Studies have shown that when applied topically to Sencarmice, tannic acid caused substantial inhibition of epidermal PAHmetabolism, subsequent PAH-DNA adduct formation, and PAH-induced skintumorigenesis. None of the above publications discloses that tannic acidis useful for the treatment of cancer.

Current standard cancer treatments include surgery, chemotherapy andradiation therapy, which often present patients with unpleasant sideeffects and, depending on the type of cancer may have limitedeffectiveness as treatments.

There is a need in the art for proven effective treatments for manytypes of cancer, with limited unpleasant side effects. The tannic acidpharmaceutical composition and method of the present invention overcomesthe deficiencies in the prior art compounds.

DISCLOSURE OF THE INVENTION

It is an object of the present invention to provide a pharmaceuticalcomposition for the treatment of cancer comprising tannic acid or tannincomplexes from the sap of a plant of the Musaceas Family and apharmaceutically acceptable carrier. The plant is preferably selectedfrom the group consisting of Musa paradisiaca (plantain); Musa CavendishEnano (banana), varieties and mixtures thereof.

It is an object of the present invention to provide a method of treatingcancer comprising administering an effective amount of a pharmaceuticalcomposition comprising tannic acid or tannin complexes from natural orsynthetic sources. It is preferred that the pharmaceutical compositionis administered at least once daily, and more preferred that thecomposition is administered 4 times daily.

The pharmaceutical composition of the invention is advantageously usedto treat any cancer condition. Thus the invention preferably provides amethod of treating cancers including, but not limited to bladder,breast, kidney. leukemia, myeloma, liposarcoma, lymphoma, colon, penis,tongue, prostate and uterus cancers.

In an alternative embodiment the invention provides a method ofstripping N-acetyl neuraminic acid from a cancer cell surface allowingrecognition of the cancer cell by the immune system in vivo comprisingcontacting said cancer cell with tannic acid or tannin complexes.

The above and other objects of the invention will become readilyapparent to those of skill in the relevant art from the followingdetailed description and figures, wherein only the preferred embodimentsof the invention are shown and described, simply by way of illustrationof the best mode of carrying out the invention. As is readily recognizedthe invention is capable of modifications within the skill of therelevant art without departing from the spirit and scope of theinvention.

DESCRIPTION OF THE INVENTION

The present invention relates to pharmaceutical compositions comprisingtannic acid, tannin complexes or mixtures thereof, and a method oftreating cancer with tannic acid and tannin complexes. The inventionwill now be described in a manner to enable production and use of thetannic acid and tannin complex compositions for the treatment of cancer.Tannin complex compositions as used herein means hydrolyzable tannins,such as esters of sugars, usually glucose.

What is known about the cancer cells' adhesion and their invasive andmetastatic growth potential in human tumors? Tumor cells produce anouter protective covering which camouflages the cancer cells epitopestructure so the immune system cannot recognize the cells. Theprotective coating contains N-acetylneuraminic acid in a linearhomopolymer of 2-8 linked N-acetylneuraminic acid (NeuNAc) which isreferred to as polysialic acid (PSA). PSA is expressed on the adhesionmolecule NCAM (Neural Cell Adhesion Molecule) and most cell adhesionmolecules. In the cancer patient, PSA is found in extremely elevatedblood levels as well as bound to erythrocytes and other blood componentsvital to the immune response.

It has been shown experimentally that PSA-NCAM drastically increasescell to cell distances and decreases the adhesion potential on NCAM. Oneof the vehicles for this physiological change is the hydrated volume ofPSA in PSA-NCAM versus NCAM in adjacent cells. The presence of PSAdecreases adhesion via a physical impedance of overall membranecontacts. These modulatory effects of PSA are relevant to cellmigration, establishment of temporal cell-cell contacts, and cellulardifferentiation during embryonic development.

In the cancer patient, the presence of PSA is linked to a loss ofadhesion potential which facilitates the invasive and metastatic growthof the tumors as well as potential structural differentiation andreorganization of healthy cells into tumor cells, i.e., neoplasticcells.

PSA is the principal molecule involved in the masking of thetumor-specific antigens (TA) which normally binds to immune systemcomponents, decreasing the effectiveness of NCAM and other cell adhesionmolecules, and inducing differentiation of healthy cells into neoplasts.Thus, if one can obtain selective removal of PSA from tissues and thebloodstream where possible, the major limitation which makes cancerimpossible to cure, outside of operative conditions, would beeliminated. This would allow the body to attack and destroy a tumor inmuch the same way it rejects a transplanted organ.

The tannic acid and tannic acid complexes in accordance with the presentinvention binds to and precipitates N-acetylneuraminic acid bound inPSA-NCAM as well as in circulating blood and bound to erythrocytes.Tannic acid recognizes the linear homopolymer of 2-8 linked N-acetylneuraminic acid, with the exposed amino group at the fifth (5) position,as an amino acid chain (protein).

The valent electrons on the nitrogen group of PSA bind covalently to thecarbonyl group of tannic acid, linking the chains of the tannic acidmoiety. The resulting bond is a very stable one with several resonancestructures. See scheme 1 below.

Three moles of N-acetylneuraminic acid are bound to each mole of tannicacid in solution. When this activity is studied, and considering theinteresting property of PSA to undergo depolymerization under mildlyacidic conditions, this evidences that the reaction between tannic acidand PSA (leading to precipitation of three moles of N-AcetylneuraminicAcid for every mole of tannic acid) is a highly favored and facilitatedreaction.

The tannic acid and tannin complexes act by stripping N-Acetylneuraminic acid from the cell surface moiety. The tannic acid,therefore, acts as an astringent. In so doing, tannic acid and tannincomplexes affect the cell changes discussed previously, allowing thebody's own immune system to reject cancerous growth in much the same wayit rejects any foreign invader.

The tannic acid and tannin complexes of the present invention exposescancer cell epitopes that were previously camouflaged by the PSA. At thesame time tannic acid and tannin complexes elevate the immune responseby freeing the circulating blood components from bound PSA.

The most predominant target of PSA in its propagation of an immunedeficient condition in cancer patients is the macrophage, a cell thatnot only phagocytizes unfriendly cells but also activates thecell-mediated and humoral-immune response. It is believed that thecancer cell, by the secretion of N-acetylneuraminic acid and itspolymerization into PSA, induces an immune deficiency which is reversedby the action of tannic acid and tannin complexes. No one knows exactlywhat initiates cancerous growths, but it is the inventors conclusionthat cancerous growths induce immune deficiencies.

Method of Production of Tannic Acid Product

Thus the tannic acid and tannin complexes of the present invention maybe formulated into a pharmaceutical composition for the treatment ofcancer. Tannic acid and tannin complexes in accordance with the presentinvention may be produced from natural sources or may be producedsynthetically. Tannic acid from natural sources is preferred. To obtaintannic acid extract from natural sources, the following procedure isfollowed.

To obtain the active tannic acid and tannin complexes, the trunk of anyof the plants of the Musaceas Family, for example, but not limited toMusa Paradisiaca, Musa Cavendish Enano, and related LinneoClassifications, are milled to extract the sap of the plant. The pulp isfiltered out of the sap to obtain a clear, characteristic tan liquid.

This liquid is preferably incorporated into a standard pharmaceuticalpreparation containing as its base: Sorbitol 70% Solution (20.9588%),Cremophor RH40 (partially hydrogenated castor oil)(8.8401%), Potassiumsorbate (0.15%), Methylparaben (0.038%), and Propylparaben (0.013%) w/w.The batching procedure is an FDA approved, CGMP, SOP for liquidpharmaceuticals. The total percent of tannic acid or tannin complex inthe final product should be about 5-20 percent. Preferably the amount oftannic acid or tannin complex in the final product is about 10-20percent concentration, most preferred is about 10% tannic acid and/ortannin complex based on total concentration of 100% when the activeagent is in the presence of a pharmaceutical carrier.

If the natural sources yield a percentage lower than 10%, a food gradetannic acid may be used to yield a 10% concentration. If the naturalsource yields a higher percentage than 10%, the product may be dilutedand retested to assure a 10% concentration.

To prepare tannic acid and tannin complexes from a synthetic source, thefollowing batching procedure is an FDA approved, CGMP, SOP for liquidpharmaceuticals. Food Grade Tannic Acid is dissolved into water alongwith the standard pharmaceutical preparation as described under thenatural extract. The percent tannic acid in final product is about 10percent (10%). Tannic acid (C₇₆H₅₂O₁₈) may be produced synthetically asdescribed in references cited in the Merck Index 11th Ed., abstract9023, p. 1431, Merck Publishing Company 1989, (incorporated herein byreference in its entirety).

Further, the pharmaceutical compositions of the present invention areuseful in compositions for systemic administration to humans and animalsin unit dosage forms, such as tablets, capsules, pills, powders,granules, suppositories, sterile parenteral solutions or suspensions,sterile non-parenteral solutions or suspensions oral solutions orsuspensions, oil in water or water in oil emulsions and the like,containing suitable quantities of an active ingredient.

Either fluid or solid unit dosage forms can be readily prepared for oraladministration. For example, the tannic acid or tannin complex compoundsof the invention can be mixed with conventional ingredients such asdicalciumphosphate, magnesium aluminum silicate, magnesium stearate,calcium sulfate, starch, talc, lactose, acacia, methyl cellulose andfunctionally similar materials as pharmaceutical excipients or carriers.A sustained release formulation may optionally be used. Capsules may beformulated by mixing the compound with a pharmaceutical diluent which isinert and inserting this mixture into a hard gelatin capsule having theappropriate size. If soft capsules are desired a slurry of the compoundwith an acceptable vegetable, light petroleum, or other inert oil can beencapsulated by machine into a gelatin capsule.

Suspensions, syrups and elixers may be used for oral administration offluid unit dosage forms. A fluid preparation including oil may be usedfor oil soluble forms. A vegetable oil such as corn oil, peanut oil orsunflower oil, for example, together with flavoring agents, sweetenersand any preservatives produces an acceptable fluid preparation. Asurfactant may be added to water to form a syrup for fluid unit dosages.Hydroalcoholic pharmaceutical preparations may be used having anacceptable sweetener such as sugar, saccharine or a biological sweetenerand a flavoring agent in the form of an elixer.

Pharmaceutical compositions for parenteral and suppositoryadministration can also be obtained using techniques standard in theart. The tannic acid and tannin complexes can be present in thereservoir alone or in combination form with pharmaceutical carriers. Thepharmaceutical carriers acceptable for the purpose of this invention arethe art known carriers that do not adversely affect the drug, the host,or the material comprising the drug delivery device. Suitablepharmaceutical carriers include sterile water; saline, dextrose;dextrose in water or saline; condensation products of castor oil andethylene oxide combining about 30 to about 35 moles of ethylene oxideper mole of castor oil; liquid acid; lower alkanols; oils such as cornoil; peanut oil, sesame oil and the like, with emulsifiers such as mono-or di-glyceride of a fatty acid, or a phosphatide, e.g., lecithin, andthe like; glycols; polyalkylene glycols; aqueous media in the presenceof a suspending agent, for example, sodium carboxymethyl-cellulose;sodium alginate; poly(vinylpyrolidone); and the like, alone, or withsuitable dispensing agents such as lecithin; polyoxyethylene stearate;and the like. The carrier may also contain adjuvants such as preservingstabilizing, wetting, emulsifying agents and the like.

Additional formulations for administration may be made in accordancewith methods and amounts known in the art as set forth in Remington'sPharmaceutical Sciences, 18th Ed., Wiley Publishing (1990) incorporatedherein by reference in its entirety.

Table 1 below represents recommended dosages, methods and times ofadministration and a preferred pharmaceutical formulation in accordancewith the present invention.

TABLE 1 Recommended Dosage if Plantain Syrup Before meals and at bedtime Weight Height 4 Times a day (ml) Catetory Age Kg lb. cm in. (1) (2)(3) (4) Infants 0.5-1.0 9 20 71 28 4 8 12 16 Children 1-3 13 29 90 35 612 17 23 4-6 20 44 112 44 9 18 26 35  7-10 28 62 132 52 13 25 37 50Males 11-14 45 99 157 62 40 60 80 120 15-18 66 145 176 69 58 87 116 17419-24 72 160 177 70 64 96 128 192 25-50 79 174 176 70 70 104 139 209 51+77 170 173 68 68 102 136 204 Females 11-14 46 101 157 62 40 61 81 12115-18 55 120 163 64 48 72 96 144 19-24 58 128 164 65 51 77 102 153 25-5063 138 163 64 55 83 110 165 51+ 65 143 160 63 57 86 114 171 Dosage 1.Cancer Stage 1 and other disorders during the 3 months-used asprophylactic in cancer and other diseases. 2. Cancer Stage 2 and 3during 3 months and continue with dosage (1) during another 3 months. 3.If the cancer patient has been treated with chemotherapy or radiotherapythis dosage is for three months and three months more with dosage (2).Then three additional months with dosage (1). (9 months in total). 4.Cancer in Stage 4 and terminal care, during a year. 5. All these dosagesmay be modified by the physician using methods known in the art, aftermonthly checkup. Dosages range from about 4 to about 200 ml. Maximumdosages for height and weight appear in column 4 above.

CLINICAL DATA

The following clinical data was collected on voluntary patients duringclinical experimental trials in Cuba. A 10% concentration of tannic acidwas used in all of the clinical studies set forth below.

Patient #1: 79 year old male, Prostate Carcinoma, permanent catheter wassurgically inserted. Cancer was inoperative because of cardiovascularcondition. Therapy in accordance with the present invention wasadministered at the maximum dosage for the initial three month periodaccording to “dosage administration.” Two weeks after initiation oftherapy in accordance with the invention catheter was removed. Cancerwas cured and the patient returned to normal activities with the firsttreatment period, three months. After that, he used the product for 7additional months.

Patient #2: 43 year old female, Breast carcinoma. Surgery was performedJan. 11, 1982 on left breast. The problem of metastatic growth was aconcern. Therapy in accordance with the invention was initiated for aminimal 3 month period based on patient weight, height criteria. Noadditional cancerous growths were detected anywhere in her body.

Patient #3: 51 year old female, Breast Carcinoma. Cancer diagnosed atthe Cancer Institute of Havana in the left breast. Tumor measured 5 cmsby 5 cms. Patient refused removal of breast and therapy in accordancethe invention was administered. Therapy in accordance with the inventionwas initiated based on weight/height criteria at maximum levels (seeTable 1, column 4). Tumor diminished in size after first three monthinterval to the point where it was very difficult to detect by manualexamination. Therapy in accordance with the invention continuedaccording to “dosage administration” for a period of one year. Cancernever returned to this day.

Patient #4: 54 year old female, Colon Carcinoma. She was administered 72chemotherapy dosages simultaneously with the therapy in accordance withthe invention. Her blood work throughout the chemotherapy/therapy wasnormal. She continued regular checkups and all have been negative.Maximum therapy in accordance with the invention was administered alongwith the chemotherapy.

Patient #5: 52 year old female, Carcinoma of the uterus. Surgery toremove the uterus was recommended and an operation planned. Upon openingpatient, metastatic growth throughout internal organs was detected.Uterus was not removed and patient was classified terminal. Maximumtherapy in accordance with the invention levels were administered for aperiod of one year. She was cured of the cancer throughout her body.Yearly checkups have confirmed no relapse.

Patient #6: 50 year old female. Breast Carcinoma. Operated for removalof left mammary gland in 1981. In 1982 they found the right mammarygland was also infected with cancer. Operation to remove was not anoption because metastasis was detected in the skeletal system, lungs andthe liver. She was classified terminal. Maximum therapy in accordancewith the invention was applied for a period of one year, in which time,she was cured of cancer in all organs. Semi-annual check-ups reveal norelapse.

Patient #7: 67 year old female. Carcinoma of the uterus. Cancer waspervasive throughout organ. Radiation therapy was prescribed. She hadsuch a violent reaction to the radiation that she refused furthertreatment. She underwent therapy in accordance with the invention atmaximum dosage for a period of one year. No other treatments wereapplied. Semi-annual checkups reveal no relapse.

Patient #8: 2 year old boy. Acute Lymphocytic Leukemia. Patientclassified as terminal. Therapy in accordance with the invention wasinitiated by drop-wise administration because patient was havingdifficulty swallowing. Administration was continued until patient wasable to swallow dosage after 1 week. Therapy period was one year atmaximum dosage as per weight/height criteria. Patient initially showedsigns of being cured. Relapse occurred two years after completion oftherapy through a process where the leukemia cells encysted in thetestes. Cyst ruptured at the time of relapse. Therapy in accordance withthe invention was readministered and patient was cured through a yearlong treatment period. To this date, all check-ups have been negative.Patient is now 17 years old.

Patient #9: 56 year old female. Colon Carcinoma. Experienced bowelblockage. Diverted passage of refuse but did not remove tumor. Tumor wasso large that removal was not feasible. Surgery was performed to extendher life without hope of cure. Doctors opted to bypass chemotherapy andradiation therapy fearing results of extended therapy would bedevastating. Therapy in accordance with the invention was administeredat maximum level for a period of one year. Tumor disappeared and has notreturned.

Patient #10: 38 year old female. Cancerous Lesion of the Tongue. Thelesion was about the size of a penny. Over the course of six months,conventional treatment was ineffective. The lesion grew deeper into thetongue. Therapy in accordance with the invention was administered over 3months at stage 1 with weight/height criteria. The lesion healed and thetissue of the tongue was restored to normal. No relapse.

Patient #11: 64 year old male. Carcinoma of penis. Surgery was performedto remove sexual organs (testes and penis). They found that the cancermetastasized and the patient was classified terminal. Therapy inaccordance with the invention was administered at maximum levelsimmediately after surgery for one year. He has had no relapse and iscured of the cancer that was diagnosed after his surgery.

Patient #12: 5 year old boy. Acute Lymphocytic Leukemia. Therapy inaccordance with the invention was administered at maximum levelaccording to weight/height criteria for one year. Patient initiallyshowed signs of being cured. Relapse occurred about 2 years aftercompletion of therapy in accordance with the invention through a processwhere the leukemia cells encysted in the testes. Cysts ruptured at thetime of relapse. As in Patient #8, therapy in accordance with theinvention was readministered through a period of one year. Patient wascured and subsequent check-ups have been negative. Patient is now 20years old.

Patient #13: 4 year old female. Acute Lymphocytic Leukemia. Chemotherapyhad been administered. The patient's overall reaction to thechemotherapy was very violent. There was no improvement with thechemotherapy. Therapy in accordance with the invention was administeredand immediately overall bloodwork returned to normal parameters. Therapyin accordance with the invention was administered for one year atmaximum levels according to weight/height criteria. Patient (now 19 andmarried) was cured of cancer and no relapse has occurred.

Patient #14: 21 year old male. Hodgkin's Lymphoma. Chemotherapy wasinitially applied with no improvement to condition of the disease and adevastating reaction to the chemotherapy. On patient's authority,chemotherapy was discontinued and therapy in accordance with theinvention was administered according to weight/height criteria for oneyear. Even though patient was considered terminal prior to therapy inaccordance with the invention, he was cured of disease. Subsequentcheck-ups have been negative and no relapse has been recorded.

Patient #15: 58 year old female. Breast carcinoma. Left mammary glandwas removed and because of fear of metastasis, therapy in accordancewith the invention was administered for a period of one year accordingto weight/height criteria. At the end of the therapy in accordance withthe invention, no cancer was detected. Two years after therapy inaccordance with the invention on yearly check-ups, it was discoveredthat she had carcinoma of the uterus. Therapy in accordance with theinvention was readministered for a period of one year. She was cured ofuterine cancer and ongoing check-ups have been negative. Great concernwas expressed about the possibility of metastasis but none occurred.

Patient #16: 59 year old female. Carcinoma of the Breast with metastasisin both lungs and lymph nodes. Attending physician detected cancerinitially in the lungs, but primary site was in the breast. Patient wasclassified terminal. Therapy in accordance with the invention wasadministered at maximum levels according to weight/height criteria for aperiod of one and one half year. At the end of therapy in accordancewith the invention, the Doctor declared patient cured, and was impressedby the therapy. All check-ups have since been negative for cancer.

Patient #17: 4 year old female. Monoblastic Leukemia. Chemotherapy wasadministered with no improvement to her condition, but devastating toher well being. Oral chemotherapy maintenance was discontinued byparents with only the three month periodic treatment at ongoingcheck-ups. No improvement to her condition was reported. Therapy inaccordance with the invention was initiated at maximum levels accordingto weight/height criteria for a period of one year. She was cured ofmonoblastic Leukemia and has had no relapse.

Patient #18: 41 year old female. Liposarcoma of the right thigh. Sheunderwent two unsuccessful operations to remove cancer with conditionreturning each time. Amputation was recommended for patient's survival,but patient refused. Therapy in accordance with the invention wasadministered at maximum levels according to weight/height criteria for aperiod of one year. She was cured of cancer, and has had no relapse.Patient is 54 years old and doing well.

Patient #19: 51 year old female. Multiple Myelomas. Patient was unableto walk due to metastasis in hips and ribs. No other therapy wasadministered but the therapy which was given at maximum levels for athree month period. Doctors examined X-rays taken at the end of thetherapy, and all concurred on actual regeneration of skeletal tissue andstructure. Patient's family never revealed to her that she had cancer.The therapy was designed for a one year period, but patient refusedtreatment after three months because she had gained weight. Patient diedfour years later of Myeloma.

Patient #20: 30 year old male. Hypernephroma (Cancer of Kidney). TheChief of Oncology and patient's relative were the attending physicians.Metastasis occurred in both the lungs and ribs (liver and brain werealso suspected). Patient was given less than one month to live and wasclassified terminal. Therapy in accordance with the invention wasadministered at maximum levels according to weight/height criteria for aperiod of one year. After 20 days of therapy in accordance with theinvention, regeneration of ribs had occurred, and after one month thepatient had returned to normal daily activities. At three months, thetherapy was discontinued due to matters beyond patient's control. Thepatient lived for two years after therapy, and never experienced anypain from the relapse.

Patient #21: 27 year old male. Carcinoma of the Bladder. Patient was thefirst to receive therapy (in 1951). Attending Urologist, diagnosedcarcinoma which was confirmed by two other physicians. All threephysicians performed a cystoscopic examination. The carcinoma waslocated on the right wall of the neck of the bladder. Patient's symptomswere painful urination with high levels of blood in urine. Surgery wasrecommended by all three physicians. Patient refused surgery and therapyin accordance with the invention was administered at maximum dosageaccording to weight/height criteria. Regular three month check-ups wereperformed which included a cystoscopic exam each time, and at the firstcheck-up the carcinoma had diminished in size. At 10 months, patient wasreleased from physicians care and declared cured of cancer spontaneously(physicians were unaware of therapy). The patient married a short timelater, had four healthy children, and is currently 71 years old and hassuffered no relapses.

In sum, the invention provides a pharmaceutical composition includingtannic acid and tannin complexes, and a method of treating cancer withtannic acid and tannin complexes which shows effective results in thetreatment of cancer.

The purpose of the above description and examples is to illustrate someembodiments of the present invention without implying any limitation. Itwill be apparent to those of skill in the art that various modificationsand variations may be made to the composition and method of the presentinvention without departing from the spirit or scope of the invention.All patents and publications cited herein are incorporated by referencein their entireties.

We claim:
 1. A method of treating a cancer sensitive to tannincomplexes, in a patient in need thereof, comprising administering aneffective amount of a pharmaceutical composition comprising tannincomplexes wherein the cancer is selected from the group consisting of:prostate carcinoma, breast carcinoma, colon carcinoma, carcinoma of theuterus, acute lymphocytic leukemia, cancerous lesion of the tongue,carcinoma of the penis, Hodgkins' lymphoma, monoblastic leukemia,liposarcoma, multiple myeloma bladder cancer, and hypernephroma.
 2. Themethod of treating cancer according to claim 1, wherein saidpharmaceutical composition comprises about 5-20% tannin complexes. 3.The method of treating cancer according to claim 1, wherein saidpharmaceutical composition comprises about 10% tannin complexes.
 4. Themethod of treating cancer according to claim 1, wherein saidpharmaceutical composition is administered at least once daily.
 5. Themethod of treating cancer according to claim 4, wherein saidpharmaceutical composition is administered four times daily.
 6. Themethod of treating cancer according to claim 1, wherein saidpharmaceutical composition further comprises gallic acid.
 7. The methodof treating cancer according to claim 1, wherein the tannin complexesare derived from the sap of a plant of the Musaceas Family.
 8. Themethod of treating cancer according to claim 1, wherein said effectiveamount comprises about 2.5-5% tannin complexes.
 9. The method oftreating cancer according to claim 1, wherein the tannin complexes arederived from an extract of a plant of the Musaceas Family.
 10. A methodof treating a cancer sensitive to tannin complexes, in a patient in needthereof, comprising administering an effective amount of apharmaceutical composition comprising tannin complexes.
 11. A method ofstripping N-acetyl neuraminic acid from a cancer cell surface allowingrecognition of said cancer cell by the immune system in vivo comprisingcontacting said cancer cell with an effective amount of tanniccomplexes, wherein the cancer is selected from the group consisting of:prostate carcinoma, breast carcinoma, colon carcinoma, carcinoma of theuterus, acute lymphocytic leukemia, cancerous lesion of the tongue,carcinoma of the penis, Hodgkin's lymphoma, monoblastic leukemia,liposarcoma, multiple myeloma, and hypernephroma.
 12. The method ofstripping N-acetyl neuraminic acid from a cancer cell surface allowingrecognition of said cancer cell by the immune system in vivo accordingto claim 6, wherein the tannin complexes are derived from the sap of aplant of the Musaceas Family.
 13. The method of stripping N-acetylneuraminic acid from a cancer cell surface allowing recognition of saidcancer cell by the immune system in vivo according to claim 6, whereinthe tannin complexes are derived from an extract of a plant of theMusaceas Family.
 14. A method of stripping N-acetyl neuraminic acid froma cancer cell surface allowing recognition of said cancer cell by theimmune system in vivo comprising contacting said cancer cell with aneffective amount of tannic complexes.